DESCRIPTION (Adapted from the application): Vaccines typically involve and initial dose of antigen, followed by a booster dose at some later time. The need for administration of a booster dose clearly limits the practicality of vaccines in much of the world. The objective of the proposed program is to develop a single-shot vaccine that would not require a follow-up visit for administration of the booster dose. The key to the new technology proposed in this application is the use of an osmotic core coated with a rate-controlling membrane to provide pulsatile delivery of an antigen at a predetermined time. The specific goals of Phase I include identification of suitable processing conditions for spray-drying or granulating the cores, identifications of the conditions for fluid-bed coating of the core particles with an erodible coating, and the demonstration of pulsatile delivery of an active antigen in vitro. If this work is successful, a Phase II program will be focused on further development of the technology and on in vivo demonstration of antigen release, subsequent antibody titers, and immunity. PROPOSED COMMERCIAL APPLICATION: The commercial potential for this technology is high, since single-shot vaccine formulations could be used for a wide range of antigens for human and veterinary applications. Pharmaceutical firms have expressed strong interest in this technology, if this program is successful. Specific diseases that could be addressed using this technology include HIV, diphtheria, acellular pertussis, tetanus, hepatitis, cholera, plague, yellow fever, and malaria.